NCT00167596

Brief Summary

The purpose of this study is to evaluate the usefulness of an optimization of muscle perfusion and oxygenation, as assessed by the NIRS technique, in critically ill patients with sepsis.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2005

Typical duration for phase_2

Geographic Reach
4 countries

7 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

July 20, 2016

Status Verified

July 1, 2016

Enrollment Period

3.8 years

First QC Date

September 9, 2005

Last Update Submit

July 19, 2016

Conditions

Critical IllnessSevere Sepsis

Keywords

near infrared spectroscopytissue oxygenationorgan dysfunctionmortality

Outcome Measures

Primary Outcomes (1)

  • A combined endpoint of mortality and sequential organ failure assessment (SOFA) score increase at day 7 is the primary efficacy endpoint

    Day 7

Secondary Outcomes (2)

  • duration of mechanical ventilation

    from randomization to Day 28

  • length of the hospital stay

    from randomization to Day 90

Study Arms (2)

1

EXPERIMENTAL

Early goal directed therapy based on StO2 evaluation

Device: Near Infrared Spectroscopy

2

ACTIVE COMPARATOR

Early goal directed therapy

Device: conventional

Interventions

Near Infrared SpectroscopyDEVICE

resuscitation will be based on Surviving Sepsis Campaign guidelines AND on increasing StO2 to 80% or more in at least 2 out of the 3 following sites: thenar, masseter and deltoid

1
conventionalDEVICE

resuscitation will be based according to Surviving Sepsis Campaign

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Two of four criteria for the systemic inflammatory response syndrome; and one of the following:
  • systolic blood pressure =\< 90 mm Hg; or
  • a blood lactate concentration =\> 4 mmol/l; or
  • skin marbling; or
  • impaired consciousness; or
  • urine output \< 30 ml/h.

You may not qualify if:

  • Age \< 18 years
  • Pregnancy
  • Do-not-resuscitate status
  • Advanced directives restricting implementation of the protocol
  • Obesity (body mass index \[BMI\] \> 30)
  • Anasarca

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Raymond Poincaré Hospital

Garches, 92380, France

Location

Hôpital Nord AP HM

Marseille, 13, France

Location

CHU Tours

Tours, France

Location

GERLACH Herwig

Berlin, Germany

Location

University Hospital Rostock

Rostock, 18057, Germany

Location

NANAS Serafeim

Athens, Greece

Location

EZAVALA Elizabeth

Barcelona, Spain

Location

Related Publications (1)

  • Nardi O, Zavala E, Martin C, Nanas S, Scheeren T, Polito A, Borrat X, Annane D. Targeting skeletal muscle tissue oxygenation (StO2) in adults with severe sepsis and septic shock: a randomised controlled trial (OTO-StS Study). BMJ Open. 2018 Mar 19;8(3):e017581. doi: 10.1136/bmjopen-2017-017581.

    PMID: 29555789DERIVED

MeSH Terms

Conditions

Critical IllnessSepsis

Interventions

Spectroscopy, Near-Infrared

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsInfectionsSystemic Inflammatory Response SyndromeInflammation

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisSpectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Djillali Annane, MD, PhD

    Raymond Poincaré Hospital, AP-HP

    STUDY CHAIR

  • Olivier Nardi, MD

    Raymond Poincaré Hospital, AP-HP

    STUDY DIRECTOR

  • Gwenhael Colin, MD

    Raymond Poincaré Hospital, AP-HP

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor in medicine

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 14, 2005

Study Start

July 1, 2005

Primary Completion

May 1, 2009

Study Completion

December 1, 2009

Last Updated

July 20, 2016

Record last verified: 2016-07

Locations

DE(2)FR(3)ES(1)GR(1)